Monday, April 26, 2010

Clinical Trials and Tribulations

The New York Times has an editorial about clinical trials of cancer treatments. This topic is not typically in the news, but it is important. They mainly report and endorse an institute of medicine study which argues that

...the testing operation is mired in bureaucracy and poorly coordinated. A typical trial must navigate past dozens of overlapping reviews by different boards and agencies that must approve the original concept for the trial and then the protocol that will govern how it is conducted before the investigators can start enrolling any patients.

The average time between developing the concept for a study and getting it started is about 2.5 years.

and proposes

It called for reducing and consolidating the number of cooperative groups, committees and reviews; increasing the money to support the trials; increasing the academic rewards to encourage researchers to run clinical trials; setting strict deadlines for each step in the process; and prioritizing the studies most likely to be successful.

My father has just received final approval for a phase 1 clinical cancer trial ! This was big news (he e-mailed me as soon as he got the news). I assure you that the testing operation is mired in bureacracy. I think this is a very important problem and it is important for the general public to get involved.

However, I can't help but suspect that the denounced fact that the concept must be approved before the protocol is considered is almost certainly the result of a past proposal in favor of "prioritizing the studies most likely to be successful."

Such prioritizing would be another step in addition to all existing steps. Yes it would be nice is if the most promising studies got priority. It is also nice that protocols are extremely carefully designed. Deciding which study is the most promising takes time. Setting up another committee is not a good way to consolidate and reduce bureacracy.